Ascletis Scores Phase 3 Win for Novel Acne Treatment, Prepares for Chinese Regulatory Push

Ascletis Pharma, a prominent Chinese biotech company, has announced positive results from a phase 3 clinical trial for its oral acne treatment, denifanstat. The once-daily pill demonstrated significant efficacy in treating moderate to severe acne vulgaris, potentially positioning it as a first-in-class therapy in the competitive dermatology market.

Clinical Trial Success

The phase 3 study, which enrolled 480 patients, met all three of its primary endpoints. Denifanstat, a fatty acid synthase inhibitor, showed a placebo-adjusted increase of 18.6% in the proportion of patients achieving treatment success. At Week 12, 33.2% of patients receiving denifanstat were assessed as having clear or almost clear skin, compared to 14.6% in the placebo group.

Notably, the average reduction in total skin lesions was 57.4% for denifanstat-treated patients versus 35.4% for those on placebo. The reduction in inflammatory lesions was even more pronounced, with a 63.5% decrease in the treatment group compared to 43.2% in the placebo arm.

Competitive Landscape and Market Potential

While the trial was not designed for direct comparisons, Ascletis has positioned denifanstat's results alongside those of existing acne treatments. The company claims that the 18.6% placebo-adjusted treatment success rate compares favorably to Almirall's Seysara (9.4%), doxycycline (6.7%), and clascoterone cream (11.6%).

Ascletis CEO Jinzi Jason Wu, Ph.D., expressed enthusiasm about the results, stating, "Denifanstat tablets demonstrated impressive efficacy beyond treatment success, showing significant reductions in total lesion count, inflammatory lesion count, and non-inflammatory lesion count."

The oral formulation of denifanstat may offer an advantage over topical treatments in terms of patient adherence. Additionally, its mechanism of action, which decreases cytokine secretion to inhibit facial sebum production, could potentially avoid issues such as antibiotic resistance and off-target effects associated with some existing therapies.

Regulatory Path and Company Strategy

Following these positive results, Ascletis is preparing to submit denifanstat for approval to the China National Medical Products Administration. This move aligns with the company's recent pivot towards metabolic diseases, a shift from its original focus on antiviral, cancer, and liver disease candidates.

Ascletis initially licensed the China rights to denifanstat from Sagimet Biosciences in 2019, originally exploring its potential in liver disease. However, the company's strategy has evolved, with recent emphasis on developing a weight loss pipeline featuring GLP-1 receptor agonists in both oral and subcutaneous formulations.

As Ascletis continues to refine its product portfolio and advance promising candidates like denifanstat, the pharmaceutical industry will be watching closely to see how this potential first-in-class acne treatment fares in the regulatory process and, potentially, in the competitive Chinese dermatology market.